FDA Inspection 761730 — Mediwatch Uk Ltd
The FDA completed an inspection of Mediwatch Uk Ltd on November 4, 2011 in Rugby. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 11 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 4, 2011
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Rugby (United Kingdom)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 14714 | 21 CFR 820.30(c) | Design input - Lack of or inadequate procedures |
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 2431 | 21 CFR 820.30(b) | Design plans- updated |
| 2604 | 21 CFR 820.30(e) | Design review - Lack of or inadequate procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |
| 631 | 21 CFR 803.17(a)(1) | Lack of System for Event Evaluations |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |